Additional items describe any restrictions of functioning in different domains. The CATS questionnaire does not replace a thorough clinical assessment! It is constructed as a screening instrument with emphasize on sensitivity. Children and adolescents with positive results on the CATS should be diagnosed using a semi-structured clinical interview.
There are differences in calculating the scores for children from age 7 and adolescents vs. You can either use the stop light sheet or the scoring sheet presented below, which will guide you through the process. When using the stoplight sheet or the scoring sheet do not forget that the CATS is constructed as a screening instrument and children and adolescents with positive results on the CATS should be diagnosed using a semi-structured clinical interview.
The determination of preliminary cutoff scores was done based on an estimation derived from the validation of a previous DSM-IV based questionnaire see below. For the crossover analysis, a general linear model was used to analyze improvement and deterioration in scores.
For analysis within the crossover design, dichotomized results were analyzed with a generalizing estimating equation GEE. A total of 66 cats were enrolled in the study.
Adequate randomization was achieved with no significant differences found between the groups for age, weight, or gender of the cats Chi-square test, all ns Table 1. This difference, while statistically significant, was not considered clinically significant. Fig 2 outlines the flow of cats through the study following enrollment. Following stabilization and medical management, this cat was re-enrolled in the study under the same case ID number.
Only data from the second enrollment were included in the analysis. Events occurring at each time point are outlined below. Cats removed from the efficacy analysis were retained for the safety analysis, unless otherwise noted. No significant changes were found between Day 0 and end of study laboratory results.
Overall, two cats had albumin values below the normal range on Day 78, one was mildly decreased at the start of the study, while the other moved from the normal range to below normal normal range 2. All reported adverse events occurring in cats enrolled into the study are summarized in Table 3. Six cats were withdrawn from the efficacy analysis prior to Day 78 due to adverse events. Two additional cats had clinically relevant adverse events not reported or noted until the Day 78 exam.
One cat had a mild increase in serum creatinine, while the other had been vomiting for several days prior to examination, and had a marked increase in serum creatinine requiring fluid therapy and hospitalization. These cats were withdrawn from the study with respect to efficacy analysis but are represented in the safety analysis. Analysis of individual cat patterns of activity counts revealed marked inter-cat variability Fig 3 , suggesting that between group analyses may be less appropriate than within group analyses.
For remaining analyses, activity data were summarized as average counts per minute across each treatment period, with one value describing each cat for a given period. Cats had increased activity counts when receiving meloxicam, and activity counts tended to be higher during the first treatment period than the second, and higher in the PDPP versus PPPD sequence cohort Table 4.
These plots highlight the marked inter-cat variability in activity seen throughout the study. The difference between the means was small 1. Bland-Altman plots of the D0 and D15 data showed that there were 2 outliers, both cats belonged to same owner. The plots show the majority of cats were scored as being less impaired on D15 compared to D0. There was no obvious association between increasing score and an increase or decrease in scatter Fig 4A and 4B.
Results for the parallel analysis are shown in Table 7. When raw scores total of items 1—17 without accounting for percent possible were compared, no differences between the groups were found for improvement at Day 36 or deterioration at Day Both percent possible and raw scores were evaluated in a general linear model for improvement on Day 36 and 78 for the crossover analysis, results are shown in Table 8. Deterioration was not evaluated for the crossover as not all cats had a matched post-treatment washout period Day A statistically significant treatment effect for improvement in percent of possible points was found for both 17 and 19 items meloxicam treated cats had greater improvement than placebo treated cats , however the effect appeared to be stronger for the 17 items.
Evaluation of raw scores for FMPI Q showed an improvement in meloxicam treated cats over placebo treated cats that was significant at the percent level. Analysis of owner-rated importance scores showed high variability in responses.
Importance scores relative to the overall median importance score across all respondents and all items indicated that items 1, 6, 7, 10, 11, 13, 14, 15, 16, and 17 were rated as relatively important to cats by owners of cats in the study.
Using these items alone did not detect improvement or deterioration. The items that detected significant improvement at Day 36 following meloxicam treatment were 3, 5, 6, 7, 8, 9, 10, 12, 15, 17, 18, and Items that detected significant deterioration following meloxicam administration at Day 57 were items 9, 10, and For the parallel design, we first calculated Wilcoxon rank-sums tests for improvement of total CSOM scores on Days 36 improvement and 57 deterioration.
No statistically significant differences were found between the meloxicam group and the placebo group in this analysis. In this model, there was a statistically significant time effect for change in total score owners are more likely to report improvement at Day 36 than at Day 78 but no significant treatment effect Table 9.
For the parallel design, we looked at owner reported changes in QoL, Temperament, and Happiness at Day 36 vs.
Day 15 and Day 57 vs. Day 36 for improvement from baseline, and deterioration from Day 36 levels, respectively. No statistically significant changes were found Table The deterioration in Happiness was significant at the percent level, more cats that had received meloxicam during Days 15—36 had a decrease in Happiness at Day 57 than the cats that had received placebo during Days 15— When evaluating owner reported scores rather than owner reported change for QoL, there were no significant differences between groups for Day Day 15 scores improvement or Day Day 36 scores deterioration.
No other significant effects were found for improvement. With activity monitor counts used as our reference standard, we saw a significant treatment effect of low-dose oral meloxicam in increasing activity counts in cats with degenerative joint disease.
Significantly higher levels of activity were detected in the meloxicam treated cats during the treatment periods. Inter-cat variability in activity counts were high. This is likely to be mainly due to differences in activity between cats, though reasons for these differences are unknown. Potential sources of variability include indoor vs. All cats in the study had approximately the same number of week and weekend days included in the analysis, and other factors were shown to be similar between groups of cats, so while these might contribute to individual variability, they were evenly distributed between treatment groups.
In addition, recent data from our laboratory Hansen, unpublished data indicates that the output from different accelerometers can vary significantly although each is stable over time , suggesting caution be exercised when comparing data between accelerometers.
Considering both these aspects, we therefore consider within group comparisons more appropriate. Further, we saw a significant deterioration in activity counts during the period following withdrawal of active medication in the PDPP sequence group.
The same analysis was not available for all cats in the PPPD group. Other studies using meloxicam in cats with DJD or osteoarthritis have found similar treatment effects with meloxicam on improvement of activity counts. In these studies, cats were selected based on owner-noted mobility impairment, and veterinary diagnosis of degenerative joint disease, and cats were maintained in their home environment throughout the study.
Using laboratory housed cats, Guillot et al found that night time activity counts were higher in normal non-arthritic cats than in OA cats,[ 24 ] and later found that night-time activity counts increased in cats on meloxicam at 0.
The current study detected differences between cats receiving meloxicam vs. The FMPI was developed using appropriate methods.
In the present study, although test-retest reliability of the FMPI instrument was reasonable, scores on Day 15 were significantly higher than on Day 0. Although the actual difference in number of points was small, this indicates that owners are rating their cats as significantly less impaired on Day 15 following a 2-week period of known placebo administration. We believe this justifies the use of the Day 15 scores as the baseline.
The period from Day 0-Day 15 may serve as a learning period for the owners as well as a chance for owners to better observe the behavior of their cats. By requesting owners to give a daily medication in the exact same manner as in the masked portion of the study we likely changed the observation of cats by owners, and perhaps also altered the behavior of the cat, which might explain some of the differences in repeatability found in the present study.
The present study also included a new analysis, the percent possible calculation for the FMPI, as well as enrolling more cats than the previous evaluation of the FMPI. As has been described for dogs with osteoarthritis [ 26 ], we also observed a sizeable caregiver placebo effect in owner reports during the first treatment period. Using the analysis of the percent possible score for the item FMPI excluding the two VAS scale items , this instrument is able to detect improvement in the crossover design, but not in the parallel design due to the caregiver placebo effect.
This suggests that one way to adjust for the initial caregiver placebo effect is to use a crossover study design. Using the full cross-over design allowed for a difference between groups to be detected in objective actimetry during the second treatment phase.
However, the full cross-over design creates a long, cumbersome clinical study. There are few masked, placebo controlled clinical studies assessing pain relief in client-owned cats with chronic pain [ 8 , 15 , 27 ] and large placebo effects have been seen in these studies as well. Although it has not been evaluated in detail, the placebo effect in these studies appears larger than is seen in comparable canine studies.
Study design may also be improved by better training of owners to recognize signs of pain in their cats, particularly those that are most responsive to analgesics. The use of a percent possible score for the item FMPI was also able to detect a deterioration following withdrawal of active medication that is not seen with the withdrawal of placebo.
Our measures of temperament and quality of life, and change in temperament and quality of life did not detect the presumed efficacy of meloxicam, despite previous work indicating strong relationships between the presence of DJD and both temperament [ 3 , 8 , 28 ] and quality of life.
One complaint about this design is the length of time required for the study. We believe RAW designed clinical trials may be very useful in evaluating analgesics for chronic pain management in cats, both for placebo controlled as well as analgesic comparison studies. Owner ratings of item importance for the FMPI were not fully indicative of the items in which improvement or deterioration were seen, or those where a difference was detected between meloxicam and placebo.
Future work will investigate whether owner ratings of importance can be used to give weight to individual FMPI questions for individual owners, or used to refine the structure of the FMPI.
The first step in selection of questions for an abbreviated FMPI would be to compare administration of the full instrument, with a priori decision to analyze only a subset of items, with a shortened form. However, there was no significant relationship between baseline scores of ability to stretch and baseline activity counts, despite the fact that AM data was also able to detect treatment effects and the effects of treatment withdrawal.
Previous studies with cats have looked at behavioral domains or specific behaviors that are responsive to analgesic treatment.
A study by Clarke and Bennett showed owner ratings of improvement in willingness to jump, height of jump, and gait stiffness in cats with osteoarthritis that received meloxicam. Future work should consider gathering video data on cats in the home environment, before and after treatment, and creating detailed ethograms of what behaviors are performed and change, as well as owner input on the changes they detected. This information may then form the basis of developing the next generation of CMIs.
Our data indicates that the incorporation of the final two questions on the FMPI asking about pain levels over the last 3 weeks, and pain levels today did not improve the sensitivity of the FMPI, and our current recommendations are that these are dropped from the instrument.
We believe these changes can be made without further evaluation because they were the last 2 questions on the FMPI and so deleting them will not influence how earlier questions are answered. Additional objective measures could also be incorporated into the management of cats with DJD, as well as for further development and validation of CMIs. Several objective measurement systems have been tested in cats, including peak vertical ground force reaction [ 24 , 25 , 35 ] and goniometry.
Finally, we have suggested that the data from Day 99 might not be as useful as data gathered earlier in the study. There are several reasons for this observation, including the smaller number of cats completing this time point. We found clinician impressions that owners were experiencing study fatigue, and were not as diligent in completing their surveys during this final evaluation.
The low-dose of meloxicam used was generally tolerated well by most cats, and can be regarded as efficacious in the management of DJD-associated chronic pain. This study enrolled cats with mild-moderate renal insufficiency and, as reported in Gowan,[ 14 ] overall changes in creatinine and blood urea nitrogen were not observed. While the cats in the PPPD group had a higher decrease in albumin from Day 0 to Day 78 than those in the PDPP group, this is of unknown clinical significance in the absence of other changes.
The number of cats showing vomiting were fairly evenly distributed to active and placebo treatments. However, rates of adverse renal effects including acute kidney injury were higher during or immediately following meloxicam administration than following placebo administration, warranting further investigation. In the most extreme case, a cat on meloxicam was vomiting for several days prior to the owner reporting this to investigators.
In conclusion, when evaluating treatments for DJD-associated chronic pain, we recommend a masked, parallel study design, which incorporates a masked washout period to allow for the assessment of deterioration RAW design , and use of actimetry as a reference standard. We recommend the use of actimetry only for within group paired comparisons, and comparisons between groups in the degree of change.
Testing Locations. Test Plans. Exam Volunteer Opportunities. Exam Contacts. Why CAT? CAT is used for the NCLEX because it: Reduces the number of "easy" items that high-ability candidates receive; "easy" items tell little about a high performing candidate's ability Reduces the number of "difficult" items low-ability candidates receive; candidates tend to guess on items that are too difficult which can skew results Reduces item exposure and subsequent security risks Improves precision of measurement of the NCLEX candidate's ability related to nursing and Provides a valid and reliable measurement of nursing competence.
Therefore, an alternate rule must be used: If the candidate has not answered the minimum number of items, the result will be a failing exam. If the candidate has answered the minimum number of items, then the exam is scored by using the final ability estimate computed from responses to all completed items.
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